FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: AGENCY INFORMATION COLLECTION ACTIVITIES; SUBMISSION FOR OFFICE OF MANAGEMENT AND BUDGET REVIEW; COMMENT REQUEST; BIOSIMILARS USER FEE PROGRAM

WASHINGTON, Feb. 3 -- Food and Drug Administration has issued a notice called: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biosimilars User Fee Program.

The notice was published in the Federal Register on Feb. 3 by P. Ritu Nalubola, Associate Commissioner for Policy.

Summary: The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

For more information, contact Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St, North Bet...